The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send St Jude Medical Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-2691-2017 — St Jude Medical Inc. St. Jude Medical, Inc. recalls Proclaim 5 Elite, implantable Pulse Generator, Hello, I own a St. Jude Medical, Inc. recalls Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable that is covered by recall Z-2691-2017 from St Jude Medical Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
